SOURCE WATER CONSIDERATIONS

SOURCE WATER CONSIDERATIONS

• Source water is the water that enters the facility.

• The origin of this source water can be from natural surface waters like rivers and reservoirs, deep-bed well waters, sea waters, or some combination of these, potentially including multiple locations of each type of source water.

• Thus, source water can be supplied from these various origins (public or private), from municipalities’ on-site water sourcing, or by external delivery such as a truck. It is possible that source water may not be potable and safe to drink.

• Such water may require pretreatment to ensure that it meets drinking water standards.

• It is the responsibility of the users of any source water to ensure that the water used in the production of drug substances (API), as well as water for indirect drug product contact or for purification system feed water purposes meets, at a minimum, drinking (potable) water standards as defined by the requirements of the National Primary Drinking Water Regulations (NPDWR) (40 CFR 141) issued by the U.S. EPA or the drinking water regulations of the European Union (EU) or Japan, or the WHO drinking water guidelines (see 3.3.1 Drinking Water).

• These regulations establish limits on the types and quantities of certain chemical and microbiological contaminants and ensure that the water will contain safe quantities of chemical and microbial species.

• Where water supplies are from regulated water utility companies, less stringent monitoring may be possible because the attributes may be tested regularly and ensured by the supplier (see 9.4.5 Source Water Control).

• Water being withdrawn from a nonregulated supply should be sampled and tested appropriately at a suitable frequency that takes into account local environmental and seasonal changes and other quality fluctuations.

• Testing should ensure conformance with one of the drinking water standards discussed above.

• The use of water complying with one of these designated drinking waters as a source water allows water pretreatment systems to only be challenged to remove small quantities of potentially difficult-to-remove chemicals.

• Control of objectionable chemical contaminants at the source water stage eliminates the need to specifically test for some of them [e.g., trihalomethanes and elemental impurities (see Elemental Impurities—Limits <232>)] after the water has been further purified, assuming there is no opportunity for recontamination.

• Source waters can be used for nonproduct contact purposes such as for non-contact cooling systems.

• Such water may not normally be required to meet drinking water standards.

• Under such circumstances, the quality standards for this water when used in a pharmaceutical facility should be subject to quality standards established by the user and defensible to regulatory agencies.